Practical Steps Towards Compliance in Patient Support Programs

PSPs are much more sophisticated these days and with a larger emphasis on offering services to patients throughout their treatment plans enabling pharmaceutical companies to stay close to their clients. It includes aiding patients accurately in taking their prescription, improving adherence, better managing their disease, reducing complications, and providing financial assistance.

Among the practical ways these companies can innovate while remaining in compliance with laws, regulations, and standards include:

• Ensuring an effective compliance program is in place to support communications and training
• Ensuring adherence to existing guidelines. Data privacy is an example of this adherence
• Detailed design of the program to ensure no loose ends across the entire PSPs cycle
• Providing guidelines to the business on how to engage in PSPs. These incorporate procedures and controls that must be in place to ensure ethical behavior by those involved in the PSPs

Due to the vast amount of patient safety data that can be acquired relative to the real-world use of medications, including adverse events, they have also become an important tool for pharmacovigilance.

At present, there is a lack of specific compliance guidelines on PSPs in Asia. In addition to the treatment, there is also a potential inducement in the form of financing or equivalent. This is an area of risk that requires raising the ethical bar.

While we are witnessing a surge in government enforcement, for example, Aegerion (2017) and United Therapeutics (2018), companies need to be aware of the consequences in the event of any compromises in ethics and compliance for PSPs. They include:

• Company risks include damaged reputation, loss of business, and the tarnished integrity of the treatment process
• Patient risks may also lead to patients getting a less suitable treatment
• The physician’s integrity and the choice of treatment may be affected